Evaluation of the Alcohol Elimination Effect of TCI711 Probiotic (Bacillus Coagulans) on Adult Individuals

NCT ID: NCT04457661

Last Updated: 2021-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-13

Study Completion Date

2020-12-31

Brief Summary

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Investigating the possibility of using Bacillus coagulans TCI711 to improve the efficiency of alcohol removal in adult individuals.

Detailed Description

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Conditions

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Breath Alcohol Level

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TCI711 probiotic

Taking one capsule (containing 10\^10 of Bacillus coagulans TCI711) daily for one month

Group Type EXPERIMENTAL

Bacillus coagulans TCI711

Intervention Type DIETARY_SUPPLEMENT

Using Bacillus coagulans TCI711 for one month and implementing alcohol testing at weeks 0, 1, and 4.

Interventions

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Bacillus coagulans TCI711

Using Bacillus coagulans TCI711 for one month and implementing alcohol testing at weeks 0, 1, and 4.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers aged between 20 to 60.
* Systolic pressure below 140
* Score of C-CAGE Questionnaire below 8 (male)/6 (female)
* Prohibiting other supplements before 2 weeks of the study and during the study
* Prohibiting alcohol drinks before 24 hours of the study
* Prohibiting caffeine drinks before 12 hours of the study

Exclusion Criteria

* Alcohol or drug allergy
* Liver, kidney, cardiovascular, or chronic diseases
* Other severe disorders
* Hypertension
* Pregnancy or lactation
* Already involved in clinical testing
* Other supplements
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TCI Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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GeNext

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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20-036-A

Identifier Type: -

Identifier Source: org_study_id

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